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Monoclonal Antibodies
Barzolvolimab for Chronic Urticaria
Phase 2
Waitlist Available
Research Sponsored by Celldex Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent pruritic wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines
Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment and agree to stay on through trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 20
Awards & highlights
Study Summary
This trial will test an experimental drug to see if it can help people with a certain kind of hives who don't respond to normal treatments.
Who is the study for?
This trial is for adults with Chronic Inducible Urticaria (hives) not relieved by antihistamines. Participants must have had symptoms for at least 6 weeks, use effective contraception, and be willing to maintain a symptom diary. Excluded are those with additional risky medical conditions, active infections like HIV or hepatitis B/C, other skin conditions, pregnant/nursing women, history of anaphylaxis or recent live vaccines.Check my eligibility
What is being tested?
The study tests barzolvolimab's effectiveness on hives unresponsive to H1-antihistamines. It involves comparing barzolvolimab against a placebo in terms of clinical effects and safety. The drug's behavior in the body will also be studied.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, general discomforts such as headaches or fatigue, allergic responses potentially leading to more severe issues if one has allergies to components of barzolvolimab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had itchy hives for more than 6 weeks despite taking antihistamines.
Select...
I have been on a stable dose of a specific allergy medication for at least 4 weeks and agree to continue it during the trial.
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I developed a skin reaction quickly after a specific allergy test at two different visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with a negative provocation test at week 12
Secondary outcome measures
Change in provocation threshold and itch for ColdU
Change in provocation threshold for SD
Change in worst itch reported after provocation for ColdU
+4 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: barzolvolimab 300 mg in patients with Symptomatic DermographismExperimental Treatment1 Intervention
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
Group II: barzolvolimab 300 mg in patients with Chronic Inducible Cold UrticariaExperimental Treatment1 Intervention
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
Group III: barzolvolimab 150 mg in patients with Symptomatic DermographismExperimental Treatment1 Intervention
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
Group IV: barzolvolimab 150 mg in patients with Chronic Inducible Cold UrticariaExperimental Treatment1 Intervention
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
Group V: Placebo Comparator in patients with Chronic Inducible Cold UrticariaPlacebo Group1 Intervention
Placebo injection subcutaneous every 4 weeks for 20 weeks
Group VI: Placebo Comparator in patients with Symptomatic DermographismPlacebo Group1 Intervention
Placebo injection subcutaneous every 4 weeks for 20 weeks
Find a Location
Who is running the clinical trial?
Celldex TherapeuticsLead Sponsor
60 Previous Clinical Trials
3,674 Total Patients Enrolled
2 Trials studying Chronic Urticaria
253 Patients Enrolled for Chronic Urticaria
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a skin condition that is itchy in addition to chronic inducible urticaria.I am willing to keep a daily electronic diary of my symptoms and attend all study visits.I agree to use effective birth control during and for 5 months after the study.You have a positive reaction during the skin test at both the screening and randomization visits.If you get a bump at the test site within 10 minutes after using TempTest® at any temperature during the screening and randomization visits, you won't be able to participate.I haven't had a live vaccine in the last 2 months and agree not to during the study.I agree to use effective birth control during and for 150 days after the study.I do not have active HIV, hepatitis B, or hepatitis C.I am 18 years old or older.I have had itchy hives for more than 6 weeks despite taking antihistamines.I am 18 years old or older.I have been on a stable dose of a specific allergy medication for at least 4 weeks and agree to continue it during the trial.Your urine output has been less than 12 milliliters per hour in the two weeks before starting treatment.Your urine color has been very dark for the two weeks before starting the treatment.I have had chronic cold urticaria or severe discomfort for 3 months or more.I am not pregnant or nursing.You must show a small bump on your skin within 10 minutes of using TempTest® at any temperature during the screening and randomization visits.You have had a severe allergic reaction called anaphylaxis in the past.I have chronic hives not caused by cold or sweating that could affect study results.You have had a positive reaction to a provocation test.I developed a skin reaction quickly after a specific allergy test at two different visits.
Research Study Groups:
This trial has the following groups:- Group 1: barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria
- Group 2: Placebo Comparator in patients with Chronic Inducible Cold Urticaria
- Group 3: Placebo Comparator in patients with Symptomatic Dermographism
- Group 4: barzolvolimab 300 mg in patients with Symptomatic Dermographism
- Group 5: barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria
- Group 6: barzolvolimab 150 mg in patients with Symptomatic Dermographism
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If this study were a success, how many other hospitals could potentially benefit from its findings?
"There are currently 14 sites enrolling patients in this trial. If you're looking to minimize travel requirements, try and select a location near Murray, Centennial or Paradise Valley. The other locations can be found on the website."
Answered by AI
Could you please tell us about barzolvolimab's safety record?
"There is some data supporting the safety of barzolvolimab, but none yet for efficacy. It received a score of 2."
Answered by AI
How many people total will be participating in this experiment?
"That is correct. The clinical trial in question, which can be found on the aforementioned website, is currently seeking 180 participants from 14 different locations."
Answered by AI
Are new participants still being accepted into this research initiative?
"The latest information from clinicaltrials.gov shows that this trial is ongoing and looking for volunteers. The first posting was on 6/28/2022, with the most recent update happening on 11/10/2022."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
North Carolina
How old are they?
18 - 65
What site did they apply to?
Dawes Fretzin Dermatology Group, LLC - Anderson
Sarasota Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
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